Cleared Traditional

K780224 - MICROCELL COUNTER MODEL CC-108

K780224 is the FDA 510(k) clearance for MICROCELL COUNTER MODEL CC-108 by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKL) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K780224 · Toa Medical Electronics USA, Inc. · Hematology device
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May 1978
Decision
105d
Days
Class 2
Risk

K780224 is an FDA 510(k) clearance for the MICROCELL COUNTER MODEL CC-108. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 19, 1978 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K780224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1978
Decision Date May 19, 1978
Days to Decision 105 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 113d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKL Counter, Cell, Automated (particle Counter)

All 53
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K780224.
COULTER COUNTER MODEL S PLUS
K792537 · Coulter Electronics, Inc. · Jan 1980
COULTER COUNTER-BLOOD CELL COUNTER
K792668 · Coulter Electronics, Inc. · Jan 1980
HEMO-W SYSTEM
K781628 · Coulter Electronics, Inc. · Oct 1978
COUNTER MODEL S PLUS BLOOD CELL COUNTER
K771512 · Coulter Electronics, Inc. · Nov 1977
AUTO. LEUCOCYTE DIFFER. ANALYZER D/90
K771728 · Technicon Instruments Corp. · Nov 1977
DETECTOTERGE AZIDE FREE
K771790 · J.T. Baker Chemical Co. · Oct 1977